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<p>A simple, precise, and robust RP-HPLC method was developed and validated for the quantitative estimation of ritonavir in nanosuspension formulations in accordance with ICH Q2(R2) guidelines. The method was evaluated for linearity, accuracy, precision, specificity, sensitivity, and robustness, demonstrating excellent linearity (r² &gt; 0.999) and high precision and accuracy. Ritonavir nanosuspension was characterized for particle size, zeta potential, drug content, and in vitro drug release to assess formulation performance and stability. The optimized formulation exhibited uniform particle size suitable for nanosuspension delivery, a zeta potential indicative of physical stability, and a drug content of 92.96 ± 0.15%. Differential scanning calorimetry confirmed the physical stability of the drug within the formulation. In vitro diffusion studies demonstrated controlled drug release. Stability studies under accelerated and long-term conditions showed no significant changes in drug content or chromatographic performance. The developed RP-HPLC method was successfully applied for routine analysis and stability profiling of ritonavir nanosuspension, confirming its suitability for quality control and stability assessment.</p>

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Analytical Method Development and Stability Profiling of Ritonavir Nanosuspension Using RP-HPLC

  • 期刊论文

  • 发表日期：

    2026年5月4日

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  • Eknath D. Ahire,
  • Smita P. Kakad,
  • Mayuri Pawar,
  • Prerna Ghatol,
  • Sneha Palaskar,
  • Sanjay J. Kshirsagar

摘要

A simple, precise, and robust RP-HPLC method was developed and validated for the quantitative estimation of ritonavir in nanosuspension formulations in accordance with ICH Q2(R2) guidelines. The method was evaluated for linearity, accuracy, precision, specificity, sensitivity, and robustness, demonstrating excellent linearity (r² > 0.999) and high precision and accuracy. Ritonavir nanosuspension was characterized for particle size, zeta potential, drug content, and in vitro drug release to assess formulation performance and stability. The optimized formulation exhibited uniform particle size suitable for nanosuspension delivery, a zeta potential indicative of physical stability, and a drug content of 92.96 ± 0.15%. Differential scanning calorimetry confirmed the physical stability of the drug within the formulation. In vitro diffusion studies demonstrated controlled drug release. Stability studies under accelerated and long-term conditions showed no significant changes in drug content or chromatographic performance. The developed RP-HPLC method was successfully applied for routine analysis and stability profiling of ritonavir nanosuspension, confirming its suitability for quality control and stability assessment.